The following data is part of a premarket notification filed by W.l. Gore And Associates Inc. with the FDA for Gore Tri-lumen Catheter.
| Device ID | K180919 |
| 510k Number | K180919 |
| Device Name: | GORE Tri-Lumen Catheter |
| Classification | Catheter, Percutaneous |
| Applicant | W.L. Gore And Associates Inc. 1505 N. Fourth St. Flagstaff, AZ 86005 |
| Contact | Michael Ivey |
| Correspondent | Michael Ivey W.L. Gore And Associates Inc. 1505 N. Fourth St. Flagstaff, AZ 86005 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-09 |
| Decision Date | 2018-10-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00733132644421 | K180919 | 000 |